Category Archives: Cardiovascular Medicine

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

Two new books and a news article triangulate some interesting thoughts on improving efficiency in medicine while causing less harm to patients – and what that really means.

IMNG Medical Media reporter Alicia Ault’s feature story on “Can More Be Done with Less?” describes a recent conference on “Avoiding Avoidable Care” that brought medical experts together to strategize on how to avoid unnecessary tests and treatment, which can harm patients.

Dr. Vikas Saini, an organizer of the conference, told her that patients often demand tests or procedures because they seek certainty and want to know that the physician cares. But test results often lead to false knowledge, said Dr. Saini of the Lown Cardiovascular Research Foundation, which cosponsored the meeting. The key for physicians, he said, is to convincingly explain to patients why the test or procedure is or is not a good idea, and to practice evidence-based medicine.

To do that, though, requires an ability to interpret medical research and help patients understand it. That’s where Dr. Marya D. Zilberberg’s new book comes in. Between the Lines: Finding the Truth in Medical Literature is a breezy 170-page primer that spends most of the first half of the book cheerleading for scientific uncertainty. She also reviews the hierarchies of quality in research and touches on heterogeneity, biases, and a few general pitfalls in interpreting studies.

The second half of Between the Lines goes a little deeper in explaining study design, validity, statistical analyses, and more, though never so deeply that a nonstatistician’s eyes will glaze over. Dr. Zilberberg, a consultant, teacher, and blogger at Healthcare, Inc., explains these dry subjects in an eminently readable fashion.

I found it a valuable refresher (especially Part Two) even though I’ve been covering medical news for over two decades, and I imagine it would be a great introduction for the uninitiated. Dr. Kenneth W. Lin, a family physician who teaches a course in evidence-based medicine at Georgetown University, posted an online review that called Between the Lines “a rare book that bridges the gulf between medical publications and the real world of practicing clinicians.” Paul D. Simmons, Ph.D., who teaches family medicine residents in Louisville, Ky., said in an online review that he hopes incorporating the book will decrease the number of residents who finish his rotation thinking that evidence-based medicine is impractical, takes too much time, requires a Ph.D. in biostatistics, and doesn’t apply to their careers.

Dr. Sweet’s scathing depictions of “efficiency” at the expense of time with patients bolster her call for “slow medicine” and the (missing) research to compare the two.

Disclosure: I’ve known Dr. Sweet for many years and even consider her a friend. I esteemed the book on its merits, and so did neurologist and author Dr. Oliver Sacks, whose book-jacket blurb called it, “A most important book, which raises fundamental questions about the nature of medicine in our time. It should be required reading.”

Dr. Abigail Zuger’s review in The New York Times began, “It is probably pointless to suggest that all the individuals presently shaping our health care future spend a quiet weekend with ‘God’s Hotel,’ Dr. Victoria Sweet’s transcendent testament to health care past. Who interrupts cowboys in the midst of a stampede? But if you’re one of the millions of doctors and patients out there choking on their dust, this is the book for you. Its compulsively readable chapters go down like restorative sips of cool water, and its hard-core subversion cheers like a shot of gin.”

The synchronicity of these three works is a sign of the times. As physicians are asked to do more with less, these writings help us understand what you’ve got to work with.

An innovative medical project that we reported in April has made the big time — a nationwide pilot program in the immense Department of Veterans Affairs system, the nation’s largest integrated health care system.

Project ECHO (Extension for Community Healthcare Outcomes) has been working wonders in New Mexico, Washington State, and a few other locations to bring specialty care to thousands of people who previously had little access to this care. Created by Dr. Sanjeev Arora of the University of New Mexico, Project ECHO connects primary care physicians with specialists in weekly case-management and educational teleconferences to give primary care physicians the support they need to manage complex patients with hepatitis C, asthma, chronic pain, rheumatic or cardiac disease, HIV, substance abuse, mental illness, high-risk pregnancy, childhood obesity, and more.

The U.S. Department of Health and Human Services awarded Project ECHO an $8.5 million Health Care Innovation grant in May 2012 to expand its operations in two states.

Impressed, the Department of Veterans Affairs cloned Project ECHO and tomorrow will launch a nationwide pilot program in the VA system that could help veterans get care in the local communities instead of traveling to specialists for treatment of heart failure, chronic pain, hepatitis C, etc. In our April 2012 video interview with Dr. Rollin M. Gallagher, deputy national program director for pain management in the Veterans Health Administration, he explains why Project ECHO is so appealing to the VA

The VA’s version, called Specialty Care Access Network-ECHO (or SCAN-ECHO), will kick off officially with a briefing by a panel of experts in Washington, D.C., that also can be viewed by Webcast (how appropriate) on Wednesday, July 11, 2012 from 10 a.m. to 11:30 a.m. Eastern time. Register here to view the Webcast.

The panel will feature Dr. Arora with Dr. Robert A. Pretzel, under-secretary for health in the V.A. system, Dr. John R. Lumpkin, director of the Health Care Group for the Robert Wood Johnson Foundation, which has funded much of Project ECHO’s work, and both specialty and primary care providers from the Cleveland VA Medical Center.

With any luck, the success of Project ECHO will echo across the country as this model of care expands.

It’s been more than a month since Dr. William Zoghbi found out about a nomination that by most measures is an opportunity of a lifetime. And the countdown to the real thing has begun.

On Monday, July 9, dressed in white, Dr. Zoghbi will relay the Olympic torch through a historic English town called Bicester.

“This is a very exciting opportunity,” said Dr. Zoghbi, who became the president of American College of Cardiology (ACC) earlier this year. “No matter how you try to imagine it, the experience would be different. But I can imagine a lot of people around me cheering me on, and your life story goes in front of you and you think about your aspirations for the future. It will be an exhilarating moment.”

The 56-year-old grew up in Lebanon. He said if it weren’t for the war, he probably wouldn’t have come to the United States in the late 1970s. “My life would have been quite different,” he said during a phone interview.

In the cheering crowd there will be his wife, his brother coming from Beirut, his friends from England and from ACC. He gets to keep the torch after his 300-meter run (roughly 0.2 miles), and he said he’s planning to display it at the Heart House, the ACC headquarters in Washington, D.C.

Dr. Zoghbi is the first from ACC to carry the Olympic torch. He is one of 22 selected by the Coca Cola Company because of his personal and professional dedication to promoting healthy lifestyles and for empowering civic engagement in communities, according to ACC. He will be representing ACC and the organization’s patient education portal, CardioSmart.

“Carrying the torch is a symbol of health in general, both mind and body,” said Dr. Zoghbi. “And my advice to physicians is that in addition to doing all the beautiful things that they do, to also think about the population in general and engage with their community in improving cardiovascular health.”

The 70-day Olympic Torch Relay leads to the Olympics Opening Ceremony on July 27. Lit in Greece, the Torch is carried by 8,000 selected participants who run through 1,000 towns and cities in the United Kingdom.

And we had to ask Dr. Zoghbi: “What is your favorite Summer Olympics sport?” Soccer, he responded. But when we asked him which team he was pulling for, he said with a laugh, “That’s a secret.”

The society is pushing forward the concept, looking at different diseases and integrating different kinds of imaging such as echo plus nuclear, Cardiac CT, or Cardiac MR, in order to get the best diagnoses, said Dr. Melissa Wood, co-director of Massachusetts General Hospital Heart Center Women’s Heart Health Program, Boston, and the chair of ASE Public Relations Committee.

“This isn’t just about echo, it’s also about all the other imaging techniques that are out there and how we can work together and deliver the highest quality of care,” said Dr. Wood in an interview. “It’s also about what’s superfluous, and what we don’t need to do.”

On the policy front, Accountable Care Organizations will be in the forefront during the meeting. Dr. Wood said that the speakers will address how “ACOs affect those of us who read echos and do them, and how they affect practices.”

Echocardiography will also leave this planet for a bit during a symposium. ASE president Dr. James Thomas has been in the past actively involved in doing research with the space station and helping pick the right echo machine to go up there, said Dr. Wood. “There’s substantial interest in microgravity and the heart, and how heart changes its function in space. It’s something that’s very unique, and there are lessons that can be learned from that, and that experience will be somehow useful in our clinical practices, whether it’s specific type of research techniques or specific types of information that are gained in that environment.”

Echocardiography is the second most commonly ordered test after EKG, according to Dr. Wood, and with the aging population, the use of the test is likely to increase.

“I see echo take off more because of this concern about heart failure being an epidemic. Echo as a way to diagnose heart failure before it becomes profound,” she said. And given the appropriate use criteria, “we’re tying to moderate the reasons echos are ordered, so they’ll continue to be fairly reimbursed by third parties and CMS (Centers for Medicare and Medicaid Services),” said Dr. Wood.

Take emergency weather warnings seriously, prepare a plan to triage and treat mass casualties, and consider how you would work in a worst-case scenario following a major natural disaster. These are some lessons learned by a thoracic surgeon who survived a devastating EF 5 tornado that ripped through his hometown of Joplin, Mo.

The tornado was on the ground for 32 minutes and cut a 6-mile-wide swath through residential and downtown areas. (Photos courtesy Dr. Michael Phillips)

Nearby St. John’s Regional Medical Center, a 360-bed hospital, “was lifted off the ground and moved four inches off its foundation.” There were 183 inpatients at St. John’s when the tornado touched down

Cars were tossed about in front of St. John’s Regional Medical Center in Joplin.

with winds approaching 300 mph on May 22, 2011. More than 70 patients, including 11 on ventilator support, “came to our hospital needing a place to stay, and we were already full. We

have a 250 bed hospital – what do you do from there?”

More than 1,000 patients were treated in the first 24 hours. There were 11 deaths in the first six hours and “I pronounced seven of them,” said Dr. Phillips, a cardiothoracic surgeon at Freeman. There were 161 deaths overall, making the Joplin tornado the deadliest on record since 1950.

“We didn’t sleep. We operated nonstop. We performed 22 operations during that time, 13 of which I performed. It was almost 30 hours before I took a break, the same thing with all the people around me,” Dr. Phillips replied. “I was really blessed by having a wonderful staff around me.”

“There were so many challenges to overcome; it’s really hard to put into words. You have to overcome that initial shock. The layperson doesn’t understand the devastation around them; you do. You have to get your arms around it and move on and deal with the situation at hand.”

A transition zone of less than 100 yards separated “completely normal from complete and total devastation.”

“One can never train enough for such an event. We have to try to be prepared as much as possible. Preparation should include all levels within the health system,” Dr. Phillips said. “Mass triage plans are critical.”

Lessons learned include taking weather warnings seriously. “We used to blow these off and we pay attention now,” Dr. Phillips said. Take shelter when a siren sounds and review your plans for worst case scenarios. All this advice applies to other natural disasters – including tsunamis, typhoons, and hurricanes, he said.

“These are all natural disasters that not only take life and create mass casualties, but they also take away our basic essentials of communications, food, clothing, and shelter.”

When researchers reported earlier this week at the American College of Cardiology’s annual meeting results from the TRA 2P-TIMI 50 trial, which tested a novel anticoagulant drug, vorapaxar, for preventing cardiovascular death, myocardial infarction (MI), and stroke in stable patients with cardiovascular disease, the results showed a questionable balance between benefit and bleeding risk that only looked good if you squinted and confined the analysis to patients with just a history of MI, no history of stroke, a body weight of at least 60 kg, and, ideally, those who were younger than 75 years old. Even within this pared-down universe, experts differed on whether vorapaxar had an unequivocal net benefit after taking into account the bleeding risk it caused.

But if vorapaxar someday gets FDA approval and appears on the U.S. market, physicians will face the tricky calculus of how to use it compared with the other new, potent antithrombotic drugs.

blood clot/courtesy Janice Carr; Public Health Image Library

Looking at vorapaxar’s performance in patients with stable cardiovascular disease, it was hard not to recall last November’s report on the ATLAS ACS 2-TIMI 51 trial, which tested adding a 2.5 mg b.i.d. dosage of another new anticoagulant drug, rivaroxaban, in acute coronary syndrome (ACS) patients also treated with aspirin and clopidogrel. In ATLAS, adding this small dose of rivaroxaban led to benefit and a bleeding risk that was strikingly similar to the pattern seen with vorapaxar in TRA 2P. Rivaroxaban on top of aspirin and clopidogrel produced an absolute, 1.6% cut in the combined rate of cardiovascular death, MI, or stroke while boosting the rate of major bleeds by an absolute 1.2%, and the rate of intracranial bleeds by 0.2%. The new vorapaxar results showed that in the best-case subgroup, adding the drug to aspirin and clopidogrel cut cardiovascular death, MI, or stroke by an absolute 1.9%, while boosting major bleeds by 1.0% and intracranial hemorrhage by 0.2%.

A big difference in the two analyses was that the benefits and risk seen with 2.5 mg rivaroxaban was in the entire study population of 5,100 patients, with no need to resort to subgroup analyses. The vorapaxar result was in about 9,500 patients, roughly 70% of all patients enrolled in the trial. Another big difference was the major impact of rivaroxaban was on cutting cardiovascular deaths. Vorapaxar’s main effect was to lower nonfatal MIs. It cut cardiovascular deaths too, but not as well as low-dose rivaroxaban.

Many experts whom I spoke with at the meeting seemed confident that low-dose rivaroxaban is on track for FDA approval later this year for treating ACS patients. Whether Merck, the company developing vorapaxar, will seek FDA approval for its drug in stable patients based on the TRA 2P data remains to be seen.

But while rivaroxaban won’t receive labeling for treating non-ACS patients, all that separates an ACS patient and a patient who is stable but with a history of prior MI is time; in fact, just a few weeks or months. The point at which an acute ACS patient becomes a stable, post-MI patient is pretty murky. Would anyone consider treating a stable, post-ACS patient with low-dose rivaroxaban? The labeling probably won’t cover it, but will the temptation be there? And the what-ifs don’t stop there.

Both the low-dose rivaroxaban study and the vorapaxar study used aspirin and clopidogrel as standard, background treatment. But U.S. physicians are increasingly switching from clopidogrel to the newer, more potent antiplatelet drugs already on the market, prasugrel and ticagrelor, several experts told me at ACC. Putting a patient on prasugrel or ticagrelor plus aspirin will likely preclude any thought of also adding rivaroxaban, not to mention vorapaxar. These combinations have not been tested, and given the bleeding risks that these drugs pose individually, the idea of using them in combination is downright scary.

After several years when clopidogrel plus aspirin reigned alone as the top treatment for preventing atherothrombotic events, the last few years brought a flurry of new agents. How these drugs compare and relate to each other, and how they are optimally used alone or in combination, will take several more years to sort out.